The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Vflex Health Care Particulate Respirator And Surgical Mask.
| Device ID | K121069 |
| 510k Number | K121069 |
| Device Name: | 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK |
| Classification | Respirator, Surgical |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Jizhong Jin |
| Correspondent | Jizhong Jin 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-09 |
| Decision Date | 2013-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50051131498568 | K121069 | 000 |
| 50051131498551 | K121069 | 000 |